# K252816: High Tone Power therapy (HiToP) (Model: HiToP PNP)

- Pathway: 510(k) (Traditional)
- Applicant: Mohammadali Nezakati
- Decided: Jun 2, 2026 after 271 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001179 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213655: HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch), Hilltek, LLC (2023) Summary page 5.

## Indications for use
HiToP® PNP is intended to be used as: Powered Muscle Stimulator (EMS): -Relaxation of muscle spasms -Increase local blood circulation -Muscle re-education -Maintaining or increasing range of motion Transcutaneous Electrical Nerve Stimulator (TENS): adjunctive use in adults to provide temporary relief of pain associated with mild to moderate diabetic peripheral neuropathy of the lower extremities. HiToP® PNP should be applied to normal, healthy, dry, and clean skin.

Source page: https://510kreport.com/device/K252816
Methodology: https://510kreport.com/methodology